Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With FANS Access Sheaths

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
NYU Langone Health
Study ID
NCT07516106
Status
Not Yet Recruiting

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Conditions

  • Kidney Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Moses Holmium:YAG laser — DEVICE
    Ho:YAG with Moses pulse modulation
  • Thulium:YAG laser — DEVICE
    p-Tm:YAG laser lithotripsy with long pulse mode

Study Details

The purpose of this study is to compare two laser technologies that are routinely used during ureteroscopy for the treatment of kidney stones. Specifically, this study will compare a pulsed Thulium:YAG laser to a pulse-modulated Holmium:YAG laser (Moses technology) to evaluate how effective and safe they are when used to break kidney stones. Primary endpoints include stone-free rate and the zero stone-free rate at a standardized postoperative. Secondary endpoints include total operative time, lasing time (s), laser energy expended (J), efficiency (laser energy expended/stone volume; stone volume/lasing time). These endpoints aim to provide a comprehensive assessment of the clinical effectiveness and procedural efficiency of the two laser systems.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pulsed Thulium:YAG laser
    Flexible Ureterorenoscopy (URS) for kidney stone treatment will be performed per standard medical care, and surgeons will use the Pulsed Thulium:YAG laser during the procedure.
  • Experimental: Pulse-modulated Holmium:YAG laser
    Flexible Ureterorenoscopy (URS) will be performed using standard techniques without deviation from routine care, and surgeons will use the pulse-modulated Holmium:YAG laser during the procedure.

Primary Outcome Measure

Stone-free rate (absence of any fragments ≥ 2mm) [ Time Frame: Month 1 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
NYU Langone HealthNew YorkNew York10016-

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By research site
Mayo Clinic Arizona· Phoenix, AZNYU Langone Health· New York, NY

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